Status:
COMPLETED
Treatment Study of Frontotemporal Dementia
Lead Sponsor:
National Institute of Neurological Disorders and Stroke (NINDS)
Conditions:
Frontotemporal Lobar Degeneration
Eligibility:
All Genders
45-95 years
Brief Summary
Objectives. The proposed clinical study has two goals: First, to assess the efficacy of a central nervous system stimulant and an atypical antipsychotic in treating the behavioral symptoms of FTD and ...
Detailed Description
Objectives. The goal of the proposed clinical study is to assess the efficacy of a central nervous system stimulant and an atypical antipsychotic in treating the behavioral symptoms of FTD. Rationale...
Eligibility Criteria
Inclusion
- INCLUSION CRITERIA:
- FTD as diagnosed by the Lund-Manchester criteria including patients with diagnoses of Semantic Dementia or Primary Progressive Aphasia.
- Ages 45 to 95 years old.
- Mild-to-moderate (CDR 1 to 2) FTD with an assigned durable power of attorney.
- EXCLUSION CRITERIA:
- Diagnosis of any form of dementia besides FTD, including AD, Lewy body dementia, vascular dementia, dementia associated with Parkinson's disease, Corticobasal Degeneration and Progressive Supranuclear Palsy.
- Severe dementia (CDR 3).
- Known allergy or serious adverse reaction to quetiapine or dextroamphetamine.
- Patient is already receiving a stimulant (methylphenidate, dextroamphetamine, pemoline, or modafinil), or an antipsychotic medication, typical or atypical, including prochlorperazine and metoclopromide.
- Patients taking any of the following medications because of their potential interaction with dextroamphetamine: MAO use currently or within 14 days prior to start of study, Furazolidone, Guanethidine, norepinephrine, sibutramine, tricyclic antidepressants, carbonic anhydrase inhibitors.
- Patients taking the following medications because of their potential interaction with quetiapine: Carbamazepine, clozapine, lithium, thioridazine.
- History of CVA, or at significantly increased risk for CVA (e.g., atrial fibrillation, recent TIA etc.).
- Symptomatic cardiovascular disease (i.e., angina, claudication, TIAs, syncope), uncontrolled hyper or hypotension, or a tic disorder.
- Any medical contraindication to performing the procedures involved in the study including blood draws or lumbar puncture.
- We will require a woman of child-bearing age to have a pregnancy test prior to starting the study medications and to use contraception during the course of the study.
- Patients with a previous negative trial of a stimulant.
- Patients with a history of severe psychosis.
- Patients with a history of recent substance abuse.
- Patients with QTc prolongation on a baseline EKG.
- A score of 2 or less on the Communication Functional Ratings - Swallowing Domain.
Exclusion
Key Trial Info
Start Date :
July 23 2004
Trial Type :
OBSERVATIONAL
End Date :
June 1 2009
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT00088751
Start Date
July 23 2004
End Date
June 1 2009
Last Update
July 2 2017
Active Locations (1)
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1
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, United States, 20892